Pfizer seeks U.S. approval of updated booster against Omicron strains

Pfizer Inc and its German partner BioNTech announced that they have submitted a request to the U.S. FDA for approval of an updated vaccine against COVID-19. It is known that the vaccine is aimed at protecting against the latest Omicron variants. The company is ready to deliver vaccine doses as soon as the FDA approval process is done.

According to a statement from Pfizer representatives, the company plans to deliver doses of COVID-19 vaccine as early as September. Earlier, it reached an agreement with the U.S. authorities to deliver 105 million doses of the vaccine, including Omicron-specific vaccines. The contract was worth $3.2 billion. 

As reported by the Pfizer CEO Albert Burl, by scaling up the production, the company will be prepared to ship the bivalent Omicron BA.4/BA.5 boosters. Meanwhile, the U.S. authorization for the variant-updated vaccine is an important step in this process.

In June, the FDA advised COVID-19 vaccine manufacturers that they should develop vaccines that offer protection against the two subvariants. According to a statement from the FDA, manufacturers will not need to submit clinical trial data, similar to how the flu vaccine is updated each year.